Table 1 Contraindications and warnings for the use of drotrecogin alfa (activated)
Contraindications | Warnings |
|---|---|
Active internal bleeding | Heparin >15 U/kg per hour |
Recent (within 3 months) hemorrhagic stroke | International Normalized Ratio > 3 |
Recent (within 2 months) intracranial or intraspinal surgery or severe head trauma requiring hospitalization | Platelet count < 30,000/mm3, even if platelet count is increased after transfusions (USA) (European Agency for the Evaluation of Medicinal Products: contraindication) |
Trauma with increased risk for life-threatening bleeding (e.g. liver, spleen or complicated pelvic fractures) | Recent gastrointestinal bleeding (within 6 weeks) |
Patients with epidural catheters | Recent administration of thrombolytic therapy (within 3 days) |
Patients with intracranial neoplasm or mass lesion, or evidence of cerebral herniation | Recent administration (< 7 days) of oral anticoagulant or glycoprotein IIb/IIIa inhibitors |
Recent administration (< 7 days) of aspirin > 650 mg/day or other platelet inhibitors | |
Recent ischemic stroke (< 3 months) | |
Intracranial arteriovenous malformation | |
Known bleeding diathesis | |
Chronic severe hepatic disease (e.g. Child–Pugh C) | |
Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location |